Senior Computer System Validation Specialist

Location: Billerica, MA

Position Type: Full time


  • Ensure validation protocols are in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations
  • Oversight of specific tests and requirements
  • Ensure all work is in line with site Computer Master Validation Plan (VMP), regulations, procedures and practices
  • Ensure that Computer VMP remains current and aligned with corporate policies
  • Review and execute Computer Systems Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP5 guidelines and regulations
  • Review and Approve risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Computer VMP
  • Review and Approve computer validation summary reports for executed protocols
  • Communicate Computer System Validation approaches and requirements during audits
  • Work with computer system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedure
  • Interpret regulatory Authority regulations, guidelines and policies


  • BS/BA in Computer Science/Business/Technical discipline
  • Minimum 8 years experience in CSV in pharmaceutical industry or related GMP environment or equivalent
  • In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP5 guidelines

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